Animal NDC 54925-036-50 Neosol
Neomycin Sulfate

Animal Product Information

Field Name Field Value
Animal NDC Code 54925-036-50
Proprietary Name Neosol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Neomycin Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Med-pharmex, Inc
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Neomycin Sulfate
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200235 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Neosol Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



(neomycin sulfate)

Antibacterial

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Approved by FDA under ANADA # 200-235

For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli  susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep and goats.

Net Weight: 50 lb. (22.6 kg) - - Each pound contains: 325 gm neomycin sulfate equivalent to 227.5 gm neomycin.

Net Wt.: 3.5 oz (100g) - - Each packet contains: 71.5 gm neomycin sulfate equivalent to 50 gm neomycin.

Restricted Drug – Use only as Directed (California)

For Oral Use in Animals Only - Add to drinking water – Not for use in liquid supplements


Dosage And Administration:



Net Weight 50 lb.  (22.6kg) Container:

Administer 10 mg neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days. Using measuring spoons, the recommended dosage can be determined as follows:

Daily Schedule for Drinking Water

SWINE

One tablespoonful* of Neosol

Solubel Powder added to water

consumed in one day will treat

 Weight of each pig

50 pigs 

10 pounds

20 pigs

25 pounds 

10 pigs

50 pounds 

CATTLE (Not to be used in veal calves)

One tablespoonful* of Neosol
Solubel Powder added to water or
 milk consumed in one day will treat

 Weight of calf

  10 calves

  50 pounds

 7calves 

  75 pounds 

4 calves 

125 pounds 

* Level Tablespoonful = US Standard Measure

The product should be added to the amount of drinking water estimated to be consumed in 12-24 hours. Provide medicated water as the sole source of water each day until consumed, followed by non-medicated water as required. Fresh medicated water should be prepared each day. For a stock solution, add six level tablespoonfuls to one gallon of water. Each pint of this stock solution will medicate 5 gallons of drinking water. For use in Automatic Proportioners delivering 2 ounces of stock solution per gallon of drinking water, dissolve 9 level tablespoonfuls in a gallon of water to make the stock solution.

Individual Animal Treatment: To provide 10 mg neomycin sulfate per pound of body weight, mix one (1) level teaspoon in water or milk for each 160 pounds body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.

Net Wt.: 3.5 oz (100g) Packet:

Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg neomycin sulfate per pound of body weight per day in divided doses maximum of 14 days.

Herd Treatment: Each packet will treat 7150 pounds body weight. Therefore, estimate the total number of pounds of body weight of the animals to be treated and administer one (1) packet (or portion thereof) for each 7150 pounds. The product should be added to the amount of drinking water estimated to be consumed in 12 - 24 hours. Provide medicated water as the sole source of water each day until consumed, followed by non-medicated water as required. Fresh medicated water should be prepared each day.

Individual Animal Treatment: To provide 10 mg neomycin sulfate per pound of body weight, mix one (1) level teaspoon in water or milk for each 160 pounds body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12 -24 hours.

Drinking Water: Swine - Use the  number of packets indicated below in 256 gallons of water or in two gallons of stock solution used in proportioner set to meter one ounce per gallon.

                                         Pig Weighing 25 to 50 pounds ----------------------2 packets

                                         Pig Weighing 50 to 100 pounds --------------------3 packets

                                         Pig Weighing Over 100 pounds ---------------------4 packets


Precautions



CAUTION: To administer the stated dosage, the concentration of neomycin required in medicated water must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects water consumption.  If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian.  If symptoms such as fever, depression, or going off feed develop, oral neomycin is not indicated as the sole treatment since systemic levels of neomycin are not obtained due to low absorption from the gastrointestinal tract

Important:  Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days. Animals not drinking or eating should be treated individually by drench.


Warnings And Precautions



WARNINGS:

Not for Use in Humans. Keep out of reach of children.

Residue Warnings: Discontinue treatment prior to slaughter by at least the number of days listed below for appropriate species:

Cattle...........................1 day

Swine and goats............3 days

Sheep..........................2 days

A withdrawal period has not been established for this product in pre-rumination calves. Do not use in calves to be processed for veal. A milk discard period has not been established for this product in lactating dairy cattle.

Do not use in female dairy cattle 20 months of age or older.

Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residue.


Storage And Handling



STORAGE:

Store in a dry place. When storing partially used containers, securely close bags to prevent contents from caking.

KEEP CONTAINER TIGHTLY CLOSED - - STORE AT ROOM TEMPERATURE

CONTACT INFORMATION:

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Med-Pharmex at (800) 587-4306. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

Manufactured by:
Med-Pharmex, Inc.
Pomona, CA 91767

Rev. July 2023


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.